FDA.reportPublic FDA data

VenoTrain soft

Primary DI
04046445000164
Brand
VenoTrain soft
Company
Bauerfeind AG
Model
21280014300233
Published
2018-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860826000VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSEBauerfeind GmbH & Co.1986-06-18DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046445000164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046445000164040464450001644046445000164

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

Regulatory Flags#

DUNS number
315914853
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046445999505VenoTrain soft212648243002312021-07-21
04046445989759VenoTrain soft212100142202322019-10-12
04046445989797VenoTrain soft212100142203222019-10-12
04046445989803VenoTrain soft212100142203232019-10-12
04046445989810VenoTrain soft212100142203242019-10-12
04046445989827VenoTrain soft212100142203312019-10-12
04046445989834VenoTrain soft212100142203322019-10-12
04046445989858VenoTrain soft212100142203342019-10-12
04057532013318VenoTrain soft212708142800092019-10-11
04057532013622VenoTrain soft212706142900092019-10-11
04046445000003VenoTrain soft212800142202332018-06-23
04046445000010VenoTrain soft212800142202342018-06-23
04046445000027VenoTrain soft212800142203212018-06-23
04046445000126VenoTrain soft212800143002232018-06-23
04046445000133VenoTrain soft212800143002242018-06-23
04046445000140VenoTrain soft212800143002312018-06-23
04046445000171VenoTrain soft212800143002342018-06-23
04046445000249VenoTrain soft212800143003332018-06-23
04046445000256VenoTrain soft212800143003342018-06-23
04046445000263VenoTrain soft212800143202212018-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026358026697VenoTrain softBauerfeind AGDWL2016-10-07
04026358026703VenoTrain softBauerfeind AGDWL2016-10-07
04026358026710VenoTrain softBauerfeind AGDWL2016-10-07
04026358026727VenoTrain softBauerfeind AGDWL2016-10-07
04026358026741VenoTrain softBauerfeind AGDWL2016-10-07
04026358026857VenoTrain softBauerfeind AGDWL2016-10-07
04026358026871VenoTrain softBauerfeind AGDWL2016-10-07
04026358026888VenoTrain softBauerfeind AGDWL2016-10-07
04026358027298VenoTrain softBauerfeind AGDWL2016-10-07
04026358027304VenoTrain softBauerfeind AGDWL2016-10-07
04026358027359VenoTrain softBauerfeind AGDWL2016-10-07
04026358027366VenoTrain softBauerfeind AGDWL2016-10-07
04026358027434VenoTrain softBauerfeind AGDWL2016-10-07
04026358027441VenoTrain softBauerfeind AGDWL2016-10-07
04026358027458VenoTrain softBauerfeind AGDWL2016-10-07
04026358027465VenoTrain softBauerfeind AGDWL2016-10-07
04026358027595VenoTrain softBauerfeind AGDWL2016-10-07
04026358027762VenoTrain softBauerfeind AGDWL2016-10-07
04026358027830VenoTrain softBauerfeind AGDWL2016-10-07
04026358027854VenoTrain softBauerfeind AGDWL2016-10-07
04026358026598VenoTrain softBauerfeind AGDWL2016-10-07
04026358026666VenoTrain softBauerfeind AGDWL2016-10-07
04026358026680VenoTrain softBauerfeind AGDWL2016-10-07
04026358026734VenoTrain softBauerfeind AGDWL2016-10-07
04026358026840VenoTrain softBauerfeind AGDWL2016-10-07
04026358027274VenoTrain softBauerfeind AGDWL2016-10-07
04026358027281VenoTrain softBauerfeind AGDWL2016-10-07
04026358027373VenoTrain softBauerfeind AGDWL2016-10-07
04026358027380VenoTrain softBauerfeind AGDWL2016-10-07
04026358027519VenoTrain softBauerfeind AGDWL2016-10-07